Increasing Animal Research Data Sharing: an

Industry Perspective
Ghislaine Poirier
ILAR meeting, 3-4 J une 2014
Property of GlaxoSmithKline
Content
Context
What is data?
Why data sharing?
Opportunities for data sharing
Establishing an animal research data sharing strategy
Context
2011: Future of Animals in Research (FAIR) Project
6-month project commissioned by head of R&D and run in the CEOs office
Strategy endorsed by the Company Executive & the R&D Executive teams
2012: Social Responsibility Commitment
to rigorously challenge the need for animal studies, and work to minimise the impact on animal
welfare by investing in the development of alternatives and through sharing animal-based data
Walled Garden Project
Leverage
animal model
data
Bolster
external
collaborations
Enhance
scientific
reviews
Boost
innovations in
alternatives
Increasing Animal Model Data Sharing Internally and Externally
Data, information and knowledge
Design
study
Ethical
review
Conduct
study
Capture
results
Analyse
results
Write a
report
Archive
report
Re-use
data
Animal Research
Data Lifecycle
Data
Results, facts, observations
Raw versus processed
data
Individual versus summary
data
Information
Data presented in a context
Knowledge
Information and how it is
interpreted, i.e. opinions
Why sharing animal research data, information and
knowledge?
For transparency
Increasing calls from the public for greater transparency in
animal research
To enable independent peer-review and
cross-analysis
Standards of care
Methodological quality
Variability and reproducibility
Analysis of bias in the results
Translational impact
To enable the development of new scientific
hypotheses
To avoid un-necessary duplication of work EVIDENCE BASED DECISIONS
Whether to use an animal model
Choosing an appropriate model
Defining ways to use a model
Whether to use an animal model
Choosing an appropriate model
Defining ways to use a model
PUBLICATION BIAS
The old way of sharing scientific data: 1886
Current and emerging opportunities for sharing
Traditional ways
Posters and oral presentations at scientific meetings
Peer-reviewed scientific publications
Electronic or on paper
Open access or not
Includes context and interpretation
Emerging opportunities
Increasing trends towards collaborative partnerships
Oral presentations at Webinars
Contributions to On-line Networks
DATABASES
Peer-reviewed or not
Formatted datasets
Developing an animal research data sharing strategy
Which animal research ?
What level of information
What
Stage of the R&D process
Retrospective vs prospective
How old will the data be?
When
Public or researchers? With whom
Which type of repository? Where
Process How
Governance Approvals
PURPOSE FOR SHARING
RISK MANAGEMENT
RESOURCES
BUDGET
Risk management
Animal right activists
Could the information be misused?
Reputational risk
Insufficient context
Could the data be misinterpreted?
Reputational risk
Loss of competitiveness
Valuable or competitive information being released
Intellectual property risk
Inadvertent sharing of information the bound to third party agreement
Legal risk
Information errors
Could errors be introduced during the transfer of information to the repository?
Data integrity risk
Understanding the R&D process context
Target
Validation
Lead
Discovery
Lead
Optimisation
Phase I Phase II Phase III
Pre-clinical
Evaluation
Phase IV
Registration
& Launch
CLINICAL DATA DISCLOSURE
ANIMAL RESEARCH
Managing stakeholders: getting buy-in
Stakeholder management plan
Stakeholder map
Internal
External: private companies, other research institutions
How important they are ?
How will they be impacted?
How will they benefit?
Are they critical subject matter experts?
Are they decision makers?
Managing the cultural change
CRITICAL
Understanding habits and concerns
Teasing apart the emotional side from the rational side
Communication plan
Benefits of sharing animal research information
(2012 survey, 53 internal stakeholders)
If data could be shared externally, what scientific questions would you address
by interrogating the data?
Selection of most appropriate model
Information of model validation: Determine whether models provide data that can be
translated to the clinic
Understand sources of experimental variations (e.g. seasonal changes)
Find information on factors that affect optimal study design (e.g. animal age)
Optimize design/power calculations & reduce inter-lab variation
Search for 3Rs advances
Investigate & validate new biomarkers
Prediction & control of side effects in certain models
Has data from a particular model been replicated in another lab?
Responses to gold standard drugs could be compared
Compare results of using different dose routes
Quality of information: impact on reproducibility
Macro-
Environment
Food/water
cage-
Environment
Microbiological
status
Temp
Light
Humidity
Noise
Group size
Bedding
Enrichment
Water purification
Pathogens
Commensals
Routines
Acclimatization
Cage changes
Animal
characteristics
Age
Quality of information: Impact the efficiency and
effectiveness of re-use
Context
International documentation guidelines : ILAR, ARRIVE, GSPC, Disease-specific guidelines
Implementation needs time and resources
Format
Electronic lab notebooks
datasets in pdf format cannot be re-used easily
Standards
Standards in Safety Toxicity: GLP practices, SEND
Few standards in efficacy pharmacology
Conclusion
Data sharing has reputational, scientific and animal benefits
There is increasing trends towards data sharing, and culture change is happening, but
change management remains critical
Risk management needs to be carefully addressed
Establishing a data sharing strategy is a team exercise that requires multiple expertise,
time and resources